Kornimate/medical-research-clean huggingface dataset:
study for the evaluation of a non-invasive hemodynamic measurement in heart failure patients

Conditions: Congestive Heart Failure

Summary: track changes in non-invasive central venous pressure across hospital stay and relationship with readmission

determining the degree of congestion is important in deciding appropriate timing for discharging hospitalized heart failure patients. central venous pressure (cvp) reflects the returning blood volume to the heart and can guide therapy to relieve congestion. however, the conventional method used to measure cvp has notable limitations as it is an invasive procedure that requires placement of a central venous catheter. traditional, non-invasive methods of estimating cvp, such as physical examination and echocardiogram, are less accurate and more resource intensive. to overcome this challenge, new technology to assess cvp non-invasively using an oscillometric method has been developed. this new technology involves measurement of the enclosed zone central venous pressure (ezcvp), which, in a preclinical study, has been shown to correlate with invasive data. additionally, a previous correlation study demonstrated that the ezcvp value can be mathematically adjusted to estimate invasive cvp. the resulting value has been termed cvpni (cvp non-invasive). most recently, a limited pilot study of patients hospitalized with acute, decompensated heart failure demonstrated the feasibility of device use in this population and the expected and incremental fall in cvpni with medical treatment over the course of hospitalization. moving forward, and in order to further improve the care of patients hospitalized with heart failure, an expanded pilot study of ezcvp technology is needed to prove that changes in cvpni track with these patients' condition during admission and can be useful in their clinical care.

Eligibility criteria:
inclusion criteria: * arm circumference of 23 cm to 55 cm * subject admitted to the hospital with acute exacerbation of heart failure, with either reduced or preserved ejection fraction * subject is at risk for readmission (nyha functional classification 2-3) * subject is able to understand the risks and potential benefits of participating in the study and is willing to provide written, informed consent * ezcvp indicator is high (cvpni is over 9 mmhg) at admission * subject is willing and able to comply with protocol procedures * subject tested negative for covid test after admission to the hospital exclusion criteria: * finger and upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff * pregnant (self-reported) * upper extremity dvt (currently being treated) * severe skin disease involving the upper arm(s) * study investigator may exclude patients based on clinical judgement
novel executive function training for obesity

Conditions: Overweight and Obesity

Summary: currently, the best behavioral treatments for obesity only work for 50% of adults, and of those who initially succeed, most do not maintain their weight loss. one reason for this failure may be due to neurocognitive deficits found among individuals with obesity, particularly related to executive function, which make it difficult for these adults to adhere to treatment recommendations. the proposed study aims to develop a novel executive function treatment (next), which when administered prior to the behavioral treatment, could help improve outcomes by addressing the neurocognitive deficits in adults with overweight or obesity.

first, to assist with treatment development, two groups of approximately 10 participants will be enrolled in a 12-week open-label treatment group of next. these participants will then provide qualitative feedback to help with treatment development. after the two pilot groups, a randomized control trial will evaluate next compared to standard bwl to assess feasibility, acceptability and preliminary efficacy. treatment will be 6 months long and assessments will occur at baseline, mid-treatment, post-treatment and 6-months after treatment.

Eligibility criteria:
inclusion criteria: * age 18-65 * ability to read english at a 6th grade level * bmi \>25 and ≤45 * difficulties with executive functioning exclusion criteria: * medical condition that requires physician monitoring to participate in weight control program or prohibits safely participating in recommended physical activity * psychiatric condition that could interfere with program participant (e.g., substance abuse, suicide attempt within previous 6 months, active purging) * currently pregnant, lactating or plan to be in the timespan of program follow-up * current enrollment in an organized weight control program * change in psychotropic medication or other medication that could have impact on weight during the previous 3 months * history of bariatric surgery * history of learning disorder, neurological condition or injury

Keywords: weight loss executive function
trial with autologous dendritic cell vaccination in patients with stage ii-iii her2 negative breast cancer

Conditions: Stage II Breast Cancer; Stage III Breast Cancer

Summary: molecular expression in breast cancer (bc) defines special fenotypes with different prognostic and predictive features.since the addition of trastuzumab and lapatinib to chemotherapy, her2 overexpressing tumors have become the best responders to systemic therapies, reaching pathologic complete response rates (pcr) around 50%. but her2 negative tumors (luminal a and triple negative) are characterized by low chemosensitivity (luminal a) or early distant relapse after diagnosis (triple negative bc) . in this open, prospective, non-randomized and multicentric phase ii study the investigators include stage ii and iii her2 negative bc patients that are going to receive neoadjuvant sequential chemotherapy epirubicin+ciclofosfamide x 4 and then docetaxel x 4)with an individualized vaccination with autologous dendritic cells pulsed with their own tumor. the hypothesis is that the reinforcement of the immune system with the autologous dendritic cell vaccination against her2 negative bc could increase pathologic complete responses (pcr) and disease free survival(dfs), when added to chemo, surgery and radiation therapy and in a maintenance schedule.

chemotherapy schedule: * dose dense epirubucin 100 mgr/m2 plus ciclofosfamide 600 mgr/m2 every two weeks for four cycles with with gm-csf support on day +1 (pegylated filgastrim) or on days +5 to +9 (filgastrim) subcutaneously * docetaxel 80-100 mgr/m2 every three weeks for four cycles. addition of gm-csf if docetaxel doses are \> 85 mgr/m2

Eligibility criteria:
inclusion criteria: * her2 negative and stage ii and iii breast cancer patients who benefit with neoadjuvant chemotherapy * age 18-75 * to get enough tumoral sample to elaborate the vaccine exclusion criteria: * pregnancy * severe diseases * hepatitis or hiv * need to be on immunosuppressant drugs

Keywords: breast cancer neoadjuvant chemotherapy autologous dendritic cell vaccination
a study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: this phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (aml) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. the two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. the purpose of the study is to learn which drug regimen is more likely to keep aml in check as long as possible.

this is a multicenter, randomized, phase 3 study ("seamless") comparing two drug regimens (arms) as the front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (aml) who are not candidates for intensive induction chemotherapy. in arm a, sapacitabine is administered in alternating cycles with decitabine, and in arm c decitabine is administered alone. the primary efficacy endpoint is overall survival. the study is designed to demonstrate an improvement in overall survival of arm a versus arm c.

Eligibility criteria:
inclusion criteria: * newly diagnosed aml based on who (world health organization) classification * age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator * ecog (eastern cooperative oncology group) performance status 0-2 * adequate renal function * adequate liver function * able to swallow capsules * agree to practice effective contraception * ability to understand and willingness to sign the informed consent form exclusion criteria: * aml is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement * having received any systemic anti-cancer therapy for aml or received treatment with hypomethylating agents or cytotoxic chemotherapy for preceding myelodysplastic syndrome (mds) or myeloproliferative disease (mpd) * known or suspected central nervous system (cns) involvement by leukemia * uncontrolled intercurrent illness * known hypersensitivity to decitabine * known to be hiv-positive

Keywords: aml
impact of multi-component interventions on high risk copd population

Conditions: Multimorbidity; Population Medicine; Chronic Obstructive Pulmonary Disease

Summary: study participants: high-risk copd population, defined as individuals whose score of copd-sq is 16 and above and whose age is 35 and above. copd-sq questionnaire will be assigned to a representative sample of local residents in xishui county, and they will finish the questionnaire online through mobile phone. intervention: within the intervention arm, we have constructed a population-based pay-for-performance mechanism to encourage medical practitioners to care for population health. for study participants in the intervention arm, we will ask them to finish an online copd-sq questionnaire with notification of his or her copd high risk status. those whose score exceeds 16 will be invited to do a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. for high-risk copd population in the intervention arm, we provide community-based spirometry pulmonary function test (pft) and education; if individuals whose post-bronchodilator fev1/fvc\<0.7, they will be spirometry-defined copd patients and will be encouraged to seek treatment and medication to the superior hospitals. additionally, we provide (1) two digital health intervention programs to smokers and individuals with mental health issues; (2) cbt-based health education for study participants with abnormal bmi; (3) active recruitment into national essential public health program in china for those with abnormal blood pressure and blood glucose. intensive follow-ups will be conducted at month 3 (telephone interview), month 6 (face-to-face with full steps of physical examination), and month 12. comparison: those who are assigned in the control arm, we will ask them to finish the same copd-sq online questionnaire with notification of his or her copd high risk status and a face-to-face survey. no physical examinations, community-based pulmonary function tests will be given. outcomes: the primary outcomes are copd knowledge, copd screening, and fev1 measurement at month 12.


Eligibility criteria:
inclusion criteria: * aged 35 and above; * copd-sq score is 16 and above; * residents who have lived in one township over the past 3 months and plan to reside in the same township in the upcoming year; * finished the informed consent. exclusion criteria: * pregnancy and other conditions that are not allowed to finish pulmonary function tests; * severe cognitive disorder or total loss of capability of daily living

Keywords: multi-component intervention for multimorbidity population medicine clustered rct high-risk copd population
factorial study of metoprolol succinate toprol-xl (324a)

Conditions: High Blood Pressure (Hypertension).

Summary: the purpose of this research study is to determine if treatment with the combination of metoprolol succinate and hydrochlorothiazide is more effective at lowering blood pressure than treatment with either of the two drugs alone. the study will also determine which combined doses of metoprolol succinate and hydrochlorothiazide are most effective at lowering blood pressure (without unacceptable side effects), and whether it is possible to combine both drugs in a single tablet to simplify blood pressure treatment.


Eligibility criteria:
inclusion criteria: * diastolic blood pressure between 95 and 114 mm at screening and start of treatment exclusion criteria: * significant conditions which in the opinion of the investigator place the subject at undue risk, eg renal impairment, hepatitis * known secondary causes of hypertension, eg, cushing's syndrome, renal artery stenosis, pheochromocytoma, hyperaldosteronism * systolic blood pressure greater or equal to 180 mm hg at start of trial

Keywords: high blood pressure hypertension (toprol-xl) metoprolol succinate hydrochlorothiazide
a study to evaluate the relative bioavailability and food effect of a new tablet formulation and strength of suzetrigine

Conditions: Pain

Summary: the purpose of this study is to evaluate the pharmacokinetics (pk) of suzetrigine (suz; vx-548) and its metabolite along with its safety and tolerability, in healthy participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * a total body weight greater than (\>) 50 kilogram (kg) * participants of non-childbearing potential key exclusion criteria: * history of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * any condition possibly affecting drug absorption other protocol defined inclusion/exclusion criteria may apply.
group cognitive-behavioral intervention for social anxiety in schizophrenia

Conditions: Social Anxiety; Schizophrenia

Summary: this study will explore the helpfulness of a short psychological group treatment called cognitive-behavioral therapy, or cbt. cbt is a form of therapy that is very structured and it aims to improve difficulties that are related to behaviors and emotions by first working on identifying and changing negative inaccurate thoughts. the main goal of this intervention is to see if group cbt reduces the symptoms of social anxiety in people with schizophrenia so that they can improve their social functioning and help their psychotic symptoms. the study compares the usefulness of adding cbt to standard services.

social anxiety is highly prevalent in people with schizophrenia and represents a major obstacle to positive functional outcomes. social anxiety is a treatable condition but has, in the context of psychosis, received only scant attention thus far. current existing manualized treatment for social anxiety may not be optimal for people with schizophrenia for a number of reasons described above. an adapted cbt intervention for schizophrenia must target the stigma attached to the illness, the presence of poor social skills, the presence of delusional and persecutory ideas, possible limited reading abilities, and associated cognitive deficits. the investigators propose to develop and test an adapted group cbt for social anxiety. the main objective of this research proposal is to contrast the impact of a cbt intervention for the treatment of social anxiety in schizophrenia with standard care (care as usual) on reducing symptoms of social anxiety. considering the relationship between certain characteristics of social anxiety (e.g. social withdrawal) with diminished quality of life and poor functional outcome, a secondary objective is to examine the impact of reduced social anxiety on functional outcome.

Eligibility criteria:
inclusion criteria: * diagnosis of a schizophrenia spectrum disorder; aged 18-50; be able to read and write at an intermediate level (education \> 8 years or more); social anxiety scores above 34 for the sias, above 19 for the spin and above 20 for the bsps; and the the presence of observable clinical symptoms supporting the diagnosis of a social anxiety disorder on axis i. exclusion criteria: * diagnosis of affective psychosis; currently clinically stable \[score of 3 or less of the saps ratings; global assessment scale score (endicott, et al., 1976) of ≥ 50\]; have no significant presence of social anxiety (score on scales below cut-off); hospitalized or hospitalized at the time of recruitment; and a change medication within the past 6 weeks.

Keywords: remission psychosocial functioning symptoms reduction
study on the rule and mechanism of treating functional gastrointestinal diseases from the perspective of liver and spleen

Conditions: Non-erosive Reflux Disease/Diarrheal Irritable Bowel Syndrome

Summary: to clarify the changes of intestinal flora - gut - brain axis in fgids patients represented by nerd disharmony of liver and stomach and ibs-d disharmony of liver and spleen, and confirm that the imbalance between intestinal flora and host co-metabolism is the key to the pathogenesis of functional gastrointestinal disease. to reveal the common mechanism of regulating liver and spleen (stomach) in treating fgids dynamic disorder and visceral hypersensitivity by regulating intestinal flora - intestine - brain axis disorder.


Eligibility criteria:
inclusion criteria: 1. healthy volunteers with no abnormal clinical manifestations; 2. meet the diagnostic criteria of nerd syndrome of disharmony of liver and stomach and ibs-d syndrome of liver depression and spleen deficiency. 3. aged between 18 and 70. 4. did not take antibiotics, steroids or other hormones, chinese herbal preparations (including oral and intravenous administration), microecological preparations or probiotics such as yogurt for nearly a week; 5. subjects are informed and sign informed consent voluntarily; 6. have certain reading ability. exclusion criteria: 1. patients with severe lesions of the heart, liver, kidney and other major organs, hematopoietic system, nervous system or mental diseases; 2. complicated with other organic diseases of the digestive system (such as peptic ulcer), or systemic diseases that affect the dynamics of the digestive tract (such as hyperthyroidism and diabetes); 3. ongoing or ongoing use of drugs that may affect gastrointestinal function (antidiarrals, antidepressants, anti-anxiety drugs, intestinal microflora regulation drugs, antibiotics, etc.); 4. those with a history of allergy to related drugs or severe food allergy used in the research. 5. the body is colonized with metal medical devices. (6) having a pregnancy plan within three months. -
treatment of osteoarthritis of the hip joint with intra-articular injection of microfractured autologous adipose tissue containing mesenchymal stromal cells.

Conditions: Hip Osteoarthritis; Hip Disease

Summary: the aim of the study is to evaluate the safety and efficacy up to 12 months of mf-at in the echo-guided infiltrative treatment of hip oa through clinical, subjective and objective evaluations.

for this pilot study, will be enrolled 30 patients with oa of the hip. all patients will be treated with a single infiltration of mf-at obtained by the lipogems® method. all activities of the present trial will be carried out at the rizzoli orthopaedic institute (selection and enrollment, abdominal sampling, infiltrative treatment and follow-ups). patients will undergo infiltrative treatment after collecting informed consent for study participation and biographical data. thereafter, patients will be followed up with clinical evaluation at 1-3-6-12 months follow-up.

Eligibility criteria:
inclusion criteria: 1. age between 40 and 70 years; 2. signs and symptoms of hip oa (pain intensity of at least 4 points and not more than 8 of vas pain - 0-10 scale in the previous week); 3. radiographic signs of hip oa (grade 1-2 according to tonnis classification) or mri signs (chondropathy or minimal labrum degeneration without acute lesions) even if grade 0. 4. unilateral involvement; 5. ability and consent of patients to actively participate in clinical follow-up; 6. signature of informed consent. exclusion criteria: 1. patients unable to express consent; 2. patients undergoing infiltration of other substance in the previous 6 months; 3. patients undergoing lower limb surgery to be treated in the previous 12 months; 4. patients with malignant neoplasms; 5. patients with rheumatic diseases; 6. patients with uncontrolled diabetes; 7. patients with uncontrolled thyroid metabolic disorders; 8. patients abusing alcoholic beverages, drugs or medications; 9. body mass index \> 35; 10. pregnant and/or fertile women. 11. pain intensity less than 4 points or greater than 8 in accordance with the vas scale. 12. patients with other hip pathologies: acetabular protrusion, concentric migration of the femoral head, presence of excessive deformity resulting from acetabular or femoral head dysplasia, collapse deformity, and deformed femoral head sequelae of perthes disease or osteonecrosis of the femoral head. 13. previous extensive surgery of the reference joint (osteotomy around the hip, open or arthroscopic osteochondroplasty for femoro-acetabular conflict).

Keywords: mf-at mf-at injection mesenchymal stromal cells pilot study hip micro-fragmented adipose tissue
study to assess on a molecular level the influence of a 5 % dexpanthenol ointment in subjects with superficial injuries

Conditions: Wound Healing; Cell Proliferation; Gene Expression

Summary: in previous in vitro studies it could be shown, that dexpanthenol has an influence on the gene expression of fibroblasts. the genes which are influenced by dexpanthenol play mainly a role during cell proliferating processes.the aim of this study is to investigate the molecular effect of dexpanthenol on human living skin, during wound healing.


Eligibility criteria:
inclusion criteria: * skin type i to iv * willingness to avoid intensive sunlight exposure two weeks before the start of the study and at least 2 months after removal of the stitches exclusion criteria: * active skin disease, moles, tattoos, strong pigmentation at the test area or scars in the test area that would influence the visual scoring * history of keloids and hypertrophic scars * frequent visits of tanning booths * intake of drugs interfering with the immune system (e.g. antiphlogistics, corticosteroids, immunosuppressants, and antihistamines) within 30 days before day 1 as well as during the study.

Keywords: wound healing cell proliferation gene expression